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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

SENTINELLA HORUS — Class IIa MDR by GENERAL EQUIPMENT FOR…

MD Atlas
GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A.

EUDAMED last updated this device on May 16, 2022

SENTINELLA HORUS

8437018413GAMMACAMERAN4

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A.
UDI-DI code: 08437018413287
Reference / catalog number: FP-0075

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Manufacturer information

Organization name: GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A.
SRN: ES-MF-000013779
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
Consult user manual before use

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Dec 1, 2021	Still on market

Device identification

Trade name: SENTINELLA HORUS
UDI-DI code: 08437018413287
Basic UDI-DI: 8437018413GAMMACAMERAN4
Reference / catalog number: FP-0075
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Portable gamma camera
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 185 MU10
77 MU10
63 MU10
50–60 MU27
AC100-240V/24Vdc (2x12 VDC 12Ah)
330 VA
142 MU29

EMDN nomenclature code(s)

Z11020101MOBILE GAMMA CAMERAS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.